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CLINICAL TRIAL article

Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1542231
This article is part of the Research Topic Herbal Medicines’ Safety and Clinical Application: New Strategies for Overcoming Therapeutic Challenges View all 3 articles

Yishenyangsui Granule for Degenerative Cervical Myelopathy: A randomized, double-blind, placebo-controlled trial with long-term follow-up

Provisionally accepted
He Yin He Yin 1Xin Chen Xin Chen 1Zhiwei Liu Zhiwei Liu 1,2Bo Xu Bo Xu 1Zhefeng Jin Zhefeng Jin 1Yan Liu Yan Liu 3Baoyu Qi Baoyu Qi 1Bin Tang Bin Tang 1Ping Wang Ping Wang 4Fanping Xu Fanping Xu 5Xu Wei Xu Wei 1Jie Yu Jie Yu 1Liguo Zhu Liguo Zhu 1,6*
  • 1 Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, China
  • 2 Zhangjiakou Hospital of Traditional Chinese Medicine, Zhangjiakou, Hebei Province, China
  • 3 Key Laboratory of Internal Medicine, Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China
  • 4 First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Nankai District, Tianjin, China
  • 5 Beijing Huairou Hospital of Traditional Chinese Medicine, Beijing, China
  • 6 Beijing Key Laboratory of Manipulative Technique, Beijing, China

The final, formatted version of the article will be published soon.

    Objective: This randomized controlled trial aims to evaluate the efficacy and safety of Yishenyangsui granule for treating Degenerative Cervical Myelopathy.: A randomized, double-blind, placebo-controlled clinical trial was conducted with 152 participants recruited from three centers and randomly assigned to receive either Yishenyangsui granule or placebo. The Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) score were evaluated for 32 weeks. Patient-reported outcomes including surgical treatment data, re-treatment data, and patient-reported condition were collected for long-term follow-up. This trial was approved by the ethics committee of WangJing Hospital of 2 China Academy of Chinese Medical Sciences (WJEC-KT-2016-004-P001) and was registered at the Chinese Clinical Trials Registry (ChiCTR-INR-16009723) on November 03, 2016 (Check out at https://www.chictr.org.cn/indexEN.html for a more comprehensive overview).The results showed that the improvement in JOA score at week 8 was significantly better in the Yishenyangsui granule group than in the placebo group (1.47 vs 0.43; P<0.001). Furthermore, improvements in motor function of upper/lower extremities, sensory function of upper extremities, reading ability, and recreation domain scores were also significantly superior in the Yishenyangsui granule group compared to the placebo group (P<0.05). Long-term follow-up outcomes revealed no statistical differences between groups regarding surgical treatment data or patient-reported condition (P>0.05). However, there was a significant difference detected in re-treatment data between groups with a lower rate observed among those receiving Yishenyangsui granule compared to those receiving placebo (25 [43.10%] vs 40 [68.97%]; P = 0.033), indicating its effectiveness for treating mild-to-moderate Degenerative Cervical Myelopathy. Conclusion: Yishenyangsui granule was effective in treating mild to moderate Degenerative Cervical Myelopathy. The participants have improved long-term outcomes. Conclusion: Yishenyangsui granule was effective in treating mild to moderate Degenerative Cervical Myelopathy. The participants have improved long-term outcomes.

    Keywords: Degenerative cervical myelopathy, non-surgical treatment, Chinese botanical drugs, long-term follow-up, Cervical spondylotic myelopathy

    Received: 09 Dec 2024; Accepted: 13 Jan 2025.

    Copyright: © 2025 Yin, Chen, Liu, Xu, Jin, Liu, Qi, Tang, Wang, Xu, Wei, Yu and Zhu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Liguo Zhu, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.